Adding the nonsteroidal anti-inflammatory drug diclofenac and spinal manipulation to standard care did not speed recovery for patients with acute low-back pain compared with double placebo (HR: 1.10, 95% CI: 0.76 to 1.60, P=0.609), Mark J. Hancock, M.App.Sc., of the of the University of Sydney Back Pain Research Group, and colleagues, reported in the Nov. 10 issue of The Lancet.

To determine whether adding the NSAID diclofenac and/or spinal manipulation would speed recovery, the investigators studied 240 patients with acute low-back pain who had been seen by their general practitioners and were advised to use standard therapy.

Patients were recruited by 19 physicians from 14 practices from June 2005 through October 2006. They had moderate baseline pain, moderate disability, and low fear avoidance.

In the 12-week, community-based study, all patients were given standard therapy: paracetamol (1g) four times a day until recovery or for a maximum of four weeks, and advice from the physician to remain active and avoid bed rest.

Patients were then randomly assigned to one of four groups: diclofenac 50 mg twice a day and placebo manipulation; spinal manipulation and placebo drug; diclofenac 50 mg twice daily and spinal manipulative therapy; or double placebo (the control group).

The spinal manipulative therapy included a range of low-velocity mobilization and high-velocity manipulation techniques done by physiotherapists with postgraduate training. The median number of therapy sessions per week was 2.3. The placebo therapy was detuned pulsed ultrasound.

The median time to full recovery was about two weeks and was not improved with diclofenac or spinal manipulative therapy.

As for the secondary outcomes, neither diclofenac nor manipulation had a statistically significant effect on pain, disability, function, or global perceived effect at any point in the 12-week study, the researchers said.

A systematic review of other studies using NSAIDs, although without prior quality baseline treatment, suggests that results from this trial with diclofenac can be generalized to other NSAIDs, the researchers said.

Although 22 patients had possible adverse reactions including gastrointestinal disturbances, dizziness, and heart palpitations, half of these were in the active diclofenac group and the other half was taking a placebo.

One patient taking active diclofenac had a suspected hypersensitivity reaction and ceased treatment.

At present, the active agent in manipulation therapy and the mechanisms of action are unclear. More effective types of manipulation might be possible once mechanisms of action are understood, the investigators said.

A small number of patients (28) had co-interventions during the study, which could have affected the results, the researchers acknowledged, but these interventions were similar in the active and placebo groups.

In addition, they said, compliance rates, although not perfect, were high in both groups and were representative of clinical practice.

This study suggests that these patients can be managed without exposing them to the increased risks and costs associated with NSAIDS or spinal manipulation, the researchers concluded.

In an accompanying comment, Bart W. Koes, Ph.D., of Erasmus University in Rotterdam, The Netherlands, wrote that some would argue that the type of spinal manipulation used in this study (mainly low-velocity mobilization) is not similar to high-velocity thrust techniques.

However, he said, randomized trials and a subsequent Cochrane review suggest that neither low-velocity nor high-velocity techniques have more favorable results than the other.

Additionally, the treatments used in this study were largely similar to the use of spinal manipulative therapy in common daily practice, Dr. Koes said.

The important message, he said, is that the management of acute low-back pain in primary care, namely advice and acetaminophen, is sufficient for most patients.

The trial was funded primarily by Australia's National Health and Medical Research Council. Diclofenac was donated by Alphapharm.

Co-author Richard Day, M.D., noted that he was a member of an advisory board for paracetamol for GlaxoSmithKline but that payments went to an audited hospital account for teaching and research purposes.

Dr. Koes, the comment author, declared no conflicts of interest.

Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco

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